Validation of the Metrohm 743 Rancimat

GLP (Good Laboratory Practice) requires periodic checking of the reproducibility and accuracy of analytical instruments by using Standard Operating Procedures (SOPs). This Application Bulletin is intended to provide you with a guideline for the validation of your Rancimat. A standard operating procedure is proposed which allows all the Rancimat functions which are relevant for the measurement to be checked. The limits given are to be taken as being examples of what can be achieved under normal laboratory conditions. Depending on the demands placed upon the accuracy of the measuring system, it may be necessary to redefine these limits in the standard operating procedure. If very careful work is carried out under appropriate conditions then it may be possible to achieve lower limits. The operating software for the 743 Rancimat contains prepared GLP tests for the temperature, conductivity and gas flow measurements. The operator can determine whether and which tests are to be carried out, in addition the interval between the tests and the required accuracy can also be defined. If the GLP function is activated then a comment will be made on each result report as to whether the GLP test requirements have been fulfilled. In order to be able to carry out the most important tests Metrohm offers the 6.5616.000 GLP Test Set as an option. Further information about the topics of QA, GLP and validation can also be found in the brochure "Quality management with Metrohm" which is available from your local Metrohm agency.